Pfizer and its German partner BioNTech have submitted their new COVID-19 recall — which targets the omicron BA.5 subvariant — to the Food and Drug Administration for emergency use authorization, the companies announced Monday.
If the vaccine is licensed, Pfizer has “rapidly ramped up production” to begin distribution immediately “to help protect individuals and families as we prepare for potential and winter surges,” Pfizer CEO Albert Bourla said. , in a press release.
The new boosters could be available “within weeks” for anyone over the age of 12, White House COVID coordinator Dr. Ashish Jha said in an interview with NBC News.
How the new booster targets the omicron BA.5 sub-variant
The updated booster is a bivalent vaccine containing mRNA from the original SARS-CoV-2 spike protein, which is already present in Pfizer’s first COVID-19 vaccine, combined with mRNA from the spike protein of the omicron BA.4 and BA.5 subvariants.
The BA.5 subvariant accounts for nearly 90% of new COVID-19 cases in the United States, according to the Centers for Disease Control and Prevention.
“Given the continued evolution of SARS-CoV-2 and its variants, it is of great importance that vaccines can be quickly adapted to the major omicron lineages in circulation,” said Dr Ugur Sahin, CEO and co-founder of BioNTech.
What the data show: BA.1 in humans, BA.5 in mice
Members of the FDA’s advisory committee supported targeting omicron’s BA.4 and BA.5 subvariants in June after Pfizer had already tested a new version of its vaccine against the original omicron variant, BA. 1.
These trials showed that a vaccine containing both the BA.1 strain and the original strain of SARS-CoV-2 generated up to 10 times more neutralizing antibodies against omicron, according to a press release from June.
The company has so far only tested the BA.5-specific vaccine in mice and is relying on data from the BA.1 human and BA.5 mouse trials for its application. permission.
In the study, eight mice that received the booster dose of BA.5 approximately 100 days after receiving two doses of Pfizer’s original vaccine generated an immune response.
“Relying solely on mouse data (for authorization) would be unprecedented to my knowledge and certainly raise eyebrows,” said John Moore, vaccine and virology expert at Weill Cornell Medicine in New York. “It does not replicate the human situation,” where many people were vaccinated over a year ago and have since been strengthened.
In Monday’s release, Pfizer-BioNTech said a clinical study of the updated booster in people over 12 will begin this month. A Pfizer spokesperson said data from this trial will be shared with regulators when it becomes available.
But Moore isn’t convinced the data will show that the BA.5 booster performs significantly better than the BA.1 booster, or even the original booster. The public expects the new reminder to prevent more infections, he said, but it’s likely to be only marginally more protective.
“They’re giving the public a shiny toy and they’re like, ‘Look, here’s a shiny new toy, come out and have fun with it,'” he said. “And if the public realizes that the shiny toy doesn’t come with a battery included, will that reduce confidence in future vaccines?”
Last week, UK medicines regulators were the first in the world to authorize an updated version of Moderna’s coronavirus vaccine that includes protection against the original omicron variant, BA.1.
In Monday’s statement, Pfizer and BioNTech said they also plan to submit their BA.5 recall to European drug regulators in the “coming days.”
Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT.
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